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A Phase Ib, Multi-center, Open-label Study to Evaluate the Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer Who Are Intolerant of or Who Have Progressed Despite Treatment With VEGF-targeted Therapies

Phase 1
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

A Phase Ib, Multi-center, Open-label Study to Evaluate the Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer Who Are Intolerant of or Who Have Progressed Despite Treatment With VEGF-targeted Therapies

Inclusion Criteria:

- Patients of Chinese origin who are ≥ 18 years old.

- Patients with histologically or cytologically confirmed metastatic renal cell

- Patients who are intolerant of or who have progression on or after stopping treatment
with VEGF-targeted therapies within 6 months. Note: Prior treatment with vaccine
therapy in the adjuvant setting and prior treatment with cytokines (i.e., IL-2,
Interferon) or chemotherapy is permitted.

- Patients with at least 1 measurable lesion determined according to the RECIST
Criteria Guidelines.

- Patients with history of brain metastasis who are clinically judged by the
investigator as neurologically stable following definitive radiation or surgery and
do not require corticosteroids may be enrolled in the study.

- Patients with a Karnofsky Performance Status ≥ 70%.

- Patients with adequate bone marrow function defined as ANC ≥ 1.5 x 109/L, Platelets ≥
100 x 109/L, Hgb >9 g/dL.

- Patients with adequate liver function defined as serum bilirubin ≤ 1.5 x ULN, ALT and
AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x

- Patients with adequate renal function which is defined as serum creatinine ≤ 2 x ULN.

- Women of childbearing potential must have had a negative serum pregnancy test within
14 days prior to the administration of RAD001.

- Patients must give written informed consent according to local guidelines

Exclusion Criteria:

- Patients who have received chemotherapy, immunotherapy, radio-therapy or any other
investigational agent (including pazopanib, axitinib) within 4 weeks of study entry,
or have received sunitinib® and/or sorafenib® within 2 weeks of the first dose of

- Patients who have previously received RAD001 or other mTOR inhibitors.

- Patients with a known hypersensitivity to RAD001 or other rapamycin analogs
(sirolimus, temsirolimus), or to its excipients.

- Patients who have a history of another primary malignancy ≤ 3 years, with the
exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

- Patients receiving chronic and systemic treatment with corticosteroids or another
immunosuppressive agent. Patients may receive low dose treatment of corticosteroids
with a maximum dose of 20 mg prednisone or 10 mg dexamethasone per day, if they are
being given for disorders such as rheumatoid arthritis, asthma, or adrenal
insufficiency. Topical or inhaled corticosteroids are permitted.

- Patients with a clinically significant active bleeding diathesis.

- Patients with known HIV seropositivity, hepatitis B or C seropositivity. Patients
with prior hepatitis B vaccination may be entered in the study after review of
hepatitis test results by the investigator.

- Patients who have undergone major surgery within 4 weeks prior to starting study drug
(e.g., intra-thoracic, intra-abdominal, or intra-pelvic), open biopsy, or significant
traumatic injury, or who have not recovered from the side effects of any of the

- Patients with any severe and/or uncontrolled medical conditions such as: unstable
angina pectoris,symptomatic congestive heart failure,myocardial infarction ≤ 6
months,serious uncontrolled cardiac arrhythmia, uncontrolled hypercholesterolemia
(>300 mg/dL or 7.75 mmol/L),uncontrolled diabetes (fasting glucose > 2x ULN),an
active or uncontrolled severe infection, cirrhosis, chronic or persistent active

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods. If barrier
contraceptives are used, they must be continued throughout the study by both sexes,
and up to 8 weeks after ending treatment. Hormonal contraceptives are not acceptable
as a sole method of contraception

Other protocol related inclusion/exclusion criteria

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability profile of RAD001 (10mg daily dose) in Chinese patients who are intolerant of or have progressed on or after VEGF-targeted therapy.

Outcome Time Frame:

4 month + 12 month

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


China: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

June 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • mRCC,
  • everolimus,
  • mTOR,
  • intolerant of VEGF-therapies
  • Carcinoma
  • Carcinoma, Renal Cell